Legua Pedro, Lema Juan, Moll Joy, Jiang Qi, Woods Gail, Friedland Ian
Hospital Nacional Cayetano Heredia, Lima, Peru.
Clin Ther. 2002 Mar;24(3):434-44. doi: 10.1016/s0149-2918(02)85044-5.
Ertapenem is a new, structurally unique, parenteral beta-lactam antimicrobial agent that can be administered once daily.
This study compared the local tolerability of ertapenem 1 g once a day administered intramuscularly (IM) versus IM ceftriaxone, with both drugs reconstituted in lidocaine.
In this prospective, double-blind, multicenter study, adult patients with lower respiratory tract infection, skin infection, or urinary tract infection requiring initial parenteral therapy were randomly assigned in a 3:1 ratio to treatment with IM ertapenem 1 g once daily or IM ceftriaxone 1 g once daily. Although study drugs were administered by unmasked personnel, the patients, investigators, and the sponsor medical reviewer were blinded. Patients who improved clinically could be switched to oral amoxicillin-clavulanate after at least 2 days of IM therapy. Tolerability and safety analyses were carried out for the treated population, and efficacy analyses were performed for the modified intent-to-treat population.
A total of 117 patients were randomized. The 87 patients in the ertapenem group and 30 in the ceftriaxone group received IM therapy for a mean duration of 4.1 and 3.8 days, respectively. During treatment, 35.6% (31/87) of patients treated with ertapenem and 43.3% (13/30) of those treated with ceftriaxone experienced > or =1 symptom at the local injection site; the most common symptom was tenderness, followed by pain. Symptoms were moderate to severe in only 1 patient (1.1%) in the ertapenem group and 3 patients (10.0%) in the ceftriaxone group. Clinical drug-related adverse events were reported during IM therapy in 14 patients (16.1%) in the ertapenem group and 5 patients (16.7%) in the ceftriaxone group. Mean +/- SD creatine kinase concentrations, measured in all patients, were 204.8+/-234.8 U/L at the end of IM ertapenem therapy and 382.9+/-721.1 U/L at the end of IM ceftriaxone therapy; at follow-up, values had returned to normal or had decreased in all cases.
Ertapenem 1 g (reconstituted in lidocaine) administered once daily IM was generally well tolerated. The tolerability and safety profiles of IM ertapenem therapy in this study were comparable to those of IM ceftriaxone therapy.
厄他培南是一种新型的、结构独特的肠外β-内酰胺类抗菌药物，每日给药一次。
本研究比较了每日一次肌内注射（IM）1 g厄他培南与IM头孢曲松的局部耐受性，两种药物均用利多卡因复溶。
在这项前瞻性、双盲、多中心研究中，需要初始肠外治疗的下呼吸道感染、皮肤感染或尿路感染的成年患者按3:1的比例随机分配，接受每日一次IM 1 g厄他培南或每日一次IM 1 g头孢曲松治疗。尽管研究药物由未设盲的人员给药，但患者、研究者和申办方医学审评员均处于盲态。临床症状改善的患者在IM治疗至少2天后可改用口服阿莫西林-克拉维酸。对治疗人群进行耐受性和安全性分析，对改良意向性治疗人群进行疗效分析。
共117例患者随机分组。厄他培南组的87例患者和头孢曲松组的30例患者接受IM治疗的平均持续时间分别为4.1天和3.8天。治疗期间，接受厄他培南治疗的患者中有35.6%（31/87）、接受头孢曲松治疗的患者中有43.3%（13/30）在局部注射部位出现≥1种症状；最常见的症状是压痛，其次是疼痛。厄他培南组仅1例患者（1.1%）、头孢曲松组3例患者（10.0%）的症状为中重度。IM治疗期间，厄他培南组14例患者（16.1%）和头孢曲松组5例患者（16.7%）报告了与药物相关的临床不良事件。在所有患者中测量的平均±标准差肌酸激酶浓度，在IM厄他培南治疗结束时为204.8±234.8 U/L，在IM头孢曲松治疗结束时为382.9±721.1 U/L；随访时，所有病例的值均恢复正常或下降。
每日一次IM给药1 g（用利多卡因复溶）的厄他培南耐受性一般良好。本研究中IM厄他培南治疗的耐受性和安全性与IM头孢曲松治疗相当。
